Recall Z-0100-2014 ยท GKZ Counter, Differential Cell
Sysmex America Inc
pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporation; 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan; Sysmex America, Inc; One Nelson C. White Pkwy, Mundeline, IL 60060, U.S.A. The Sysmex pocH-100i Automated Hematology Analyzer is an automated cell counter intended for in vitro diagnostic use in CLIA non-waived clinical laboratories (n
| Date | Oct 18, 2013 (initiated May 15, 2013) |
| Status | Terminated |
| Reason | The data printed on the thermal printer may omit a digit or decimal point in the results or sample identification number. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Sysmex, sent a "Product Notification-FIELD CORRECTION" letter dated May 2013 to all customers in the U.S. and Canada on May 15, 2013 by U.S. Mail. The letter describes the product, problem and actions to be taken. The customers will be contacted by a Sysmex Service Representative within the following 90 days to schedule an appointment to replace the Printed Circuit Board (PCB) on the internal printer. The repair will be performed during an on-site service visit. The customers were instructed to, until the repair can be made, use the thermal printer for reporting results; to compare t |
| Quantity | 193 units |
| Distribution | Worldwide distribution: US (Nationwide) including Puerto Rico and states of: AK, AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, SD, TN, TX, UT, VA, VT, WA, WI, and WY; and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032677 | SYSMEX POCH-100I Sysmex America, Inc., Feb 11, 2004 |